The present invention relates generally to the field of medicament delivery systems and in particular to a drug deliver platform comprising an injection device for delivering medicaments to a subject through a needle. More specifically, the present invention relates to a drug delivery platform for self-administration of an injection having one or more of a medicament delivery device with stored tissue and site specific parameters for different injections, a non-sequential user feedback control process, a training component, a failsafe component, a drug monitoring and reporting component, a compliance assistance component, and a dynamic diagnostic drug delivery component. Further, this application relates to a method for using the same.
Human error in the health care environment accounts for an estimated 98,000 deaths a year. This staggering figure exceeds the numbers of death related to automobile accidents (about 43,450), breast cancer (42,300) or AIDS (16,500) as reported by the National Academy of Science [1]. National outcry has mandated that improved systems be developed to reduce the number of mistakes made in the health care setting. There is, therefore, an unaddressed, long felt need for a means of improving patient compliance by way of training, tracking and verifying subcutaneous injections performed on patients in an outpatient setting.
A “Standard of Care” in drug administration is defined by the ability to control a variety of drug delivery parameters of the injection/infusion event and ultimately ensure patient safety and patient comfort. These elements are currently lacking as it pertains to in-home, self-administered injection devices. Such devices may be generally categorized into two groups: manual disposable syringe based devices or auto-injection “pen” devices.
Manual disposable syringe based devices have existing since the mid-1800's. In 1844, Irish physician Francis Rynd, invented the hollow needle. In 1853, two physicians, Scottish physician Alexander Wood and the French physician Charles Pravaz, independently developed first practical hypodermic syringes [2]. Companies such as Becton Dickinson (1 Becton Drive, Franklin Lakes, N.J. 07417) have developed disposable syringe based devices for over 100 years. These devices were designed for a single purpose of performing a subcutaneous injection through a hollow-bore needle affixed to the syringe device. Syringes are simple mechanical systems with no capability of refined fluid dynamics or ability to integrate advanced digital capabilities.
Auto-injection “pen” devices have recently become increasingly popular for single-dose or multi-dose, at-home self-administration. These auto-injection “pen” devices are primarily designed to accomplish two basic objectives: convenience and automation of drug delivery in an outpatient setting. These are typically mechanically spring-loaded devices that advance a plunger or rubber stopper to transfer medication via a hollow-bore needle to a patient's tissues. Auto-injection “pen” devices lack the ability to regulate flow-rate of injection, tissue exit-pressure of the injection or to integrate advanced digital capabilities. A significant limitation of auto-injection pens are the inability to control injection parameters such as flow-rate and pressure, or to collect and transfer digital information from the device to other sources.
See published international patent applications WO 2005/077441 A2 and WO 2007/088444 A1, applied for by Ares Trading S. A., which disclose hand-held electronically controlled injection devices designed to perform an injection by first mechanically advancing the needle into the subject's tissue, and then advancing a plugger for injecting the liquid drug into the tissue. The initial, and potentially most uncomfortable needle insertion step is performed by the device as part of its automated function, rather than by the subject. The speed of insertion of the needle is set by the device and automation of the insertion step may contribute to further discomfort, in that the subject may feel as though he or she has, in effect, been stabbed by the device, in a manner over which the subject has no control.
Manual syringes and auto-injection “pen” devices are devices that are designed to conveniently administer a fluid-flowing drug subcutaneously via a hollow-core needle. These devices are not designed to reduce apprehension, pain, user pain perception and/or prevent local trauma during the delivery of the medication. The inability to precisely control flow-rate and/or exit-pressure of the drug, and, in the devices that automate the insertion step, the inability to control needle insertion, further increase the chance of a negative experience by the home user, possibly leading to a reduction in home-use compliance when using such devices.
The mechanical design of these devices incorporates mechanical limitations that result in ineffective management of fluid flow specifically, and the overall inject process in general.
Another major deficiency in state of the art injection devices is that they do not provide a means for promoting user compliance for the outpatient, self-injecting segment of the market. Current manual syringes and auto-injection “pen” devices are susceptible to operator error and, as a result, lower user compliance. These operator mistakes can unfortunately lead to patient deaths and iatrogenic illnesses. There is, therefore, an unaddressed and long felt need to provide an apparatus and method for improving the safety of self-administration of medicaments, as well and improving patient drug regimen compliance.